Highlights from

EAN 2019

European Academy of Neurology

Oslo 29 June - 2 July 2019

Fremanezumab results of the FOCUS study

The overall positive efficacy and safety/tolerability results of fremanezumab in the placebo-controlled FOCUS study were reported in different posters.

Participants had episodic or chronic migraine and inadequate response to 2-4 classes of migraine preventive medications. A total of 838 patients were randomised to monthly fremanezumab (month 1: chronic migraine, 675 mg & episodic migraine, 225 mg; months 2 and 3: 225 mg), quarterly fremanezumab (month 1: 675 mg; months 2 and 3: placebo), or matched monthly placebo. Reductions in monthly average migraine days, clinically meaningful response rates within 4 weeks, and sustained ≥50% response rates over 3 months were significantly greater with fremanezumab vs placebo (both P<0.0001; see Table) [1]. Higher proportions of patients achieved ≥50% and ≥75% reductions in migraine days within 4 weeks and sustained ≥50% reductions through the 12-week treatment period with fremanezumab versus placebo.

Table: Least-squares mean change in monthly migraine days over 12 weeks [1]

EAN MCR 2019 D1-Digitaal-10a

Fremanezumab was generally safe and well-tolerated, with similar incidences of adverse events (AEs) compared with placebo [2]. The most common AEs (incidence ≥5%) were injection-site erythema, injection-site induration, and nasopharyngitis. Individual cardiovascular or hepatobiliary AEs were reported by <1% of patients in each treatment group. AEs leading to discontinuation and serious AEs were infrequent (≤1%) across treatment groups. No serious AEs were considered to be treatment-related by investigators, and no safety signals were identified.

A third analysis showed that fremanezumab treatment significantly reduced any as well as migraine-specific acute headache medication use compared with placebo in the FOCUS study [3].

  1. Spierings EL, et al. EAN 2019, EPO3113.
  2. Ferrari M, et al. EAN 2019, EPO2127.
  3. Diener HC, et al. EAN 2019, EPO1136.

The content and interpretation of these conference highlights are the views and comments of the speakers/authors.